Pulmonary Disease, Chronic ObstructiveCHOROSNCT06712563
Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 7 sites in 7 countries.
Trial summary
The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Budesonide/glycopyrrolate/formoterol fumarate
- How many people
- 2,000 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 17 Apr 2025to 14 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD who are new initiators of BGF enrolled in several planned and on-going prospective, non-interventional single-arm studies. Eligible patients for the individual studies are those with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation. Only patients that have signed an informed consent form (ICF) allowing the secondary use of their data will be eligible for the CHOROS pooled analysis.
Who may be able to join
- Patients with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation
- Enrolled in on-going single-arm studies
- Provided consent for secondary use of data
Who cannot join
- Did not provide consent for secondary use of data
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: Pooled Analysis of Multi-country, Open-label Single-arm, Non-interventional, Multi-center, Cohort Studies of Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Budesonide/glycopyrrolate/formoterol fumarate
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/glycopyrrolate/formoterol fumarateDrug
Also called BGF, Breztri
Budesonide/glycopyrrolate/formoterol fumarate (BGF) is a triple fixed-dose combination therapy for adults with moderate to severe COPD who are not adequately treated by a combination of inhaled corticosteroids and long-acting beta-agonist (LABA), or LABA and long-acting muscarinic-antagonist
| Study group | Role | What they receive |
|---|---|---|
| BGF Initiators | New initiators of BGF without prior BGF exposure Receives: Drug: Budesonide/glycopyrrolate/formoterol fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Assessment Test (CAT)
Compare self-reported COPD health status measured by COPD Assessment Test (CAT) at 12 weeks/3 months as compared to baseline in patients initiating treatment with BGF
Measured: 12 weeks
Secondary outcomes (5)
COPD Assessment Test
To compare self-reported COPD health status measured by CAT at 4 weeks/1 month as compared to baseline in patients initiating treatment with BGF
Measured: 4 weeks
COPD Assessment Test
To compare self-reported COPD health status measured by CAT at 52 weeks/12 months as compared to baseline in patients initiating treatment with BGF
Measured: 52 weeks
COPD Assessment Test Responder Rate
To describe the frequency and proportion of responders of the CAT questionnaire after 12 weeks/3 months of initiating treatment with BGF
Measured: 12 weeks
Treatment Satisfaction Questionnaire for Medication (TSQM)
To evaluate treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) after 12 weeks/3months and 52 weeks/12 months of initiating treatment with BGF
Measured: 12 weeks and 52 weeks
Annual rate of COPD exacerbations
To compare the annual rates of moderate and severe exacerbations for the follow-up period (up to 52 weeks/12 months) versus the baseline period (12 months prior to initiating BGF)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start17 Apr 2025
- Primary completion14 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Michael F Pollack, MS, Principal investigator, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712563
- Sponsor's protocol ID
- D5980R00084
- Acronym
- CHOROS
- Status last verified
- Jul 2026
- First submitted
- 27 Nov 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pooled Analysis of Multi-country, Open-label Single-arm, Non-interventional, Multi-center, Cohort Studies of Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
- ClinicalTrials.gov ID
- NCT06712563
- Acronym / sponsor ID
- CHOROS / D5980R00084
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGF Initiators | – | Drug: Budesonide/glycopyrrolate/formoterol fumarateNew initiators of BGF without prior BGF exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD who are new initiators of BGF enrolled in several planned and on-going prospective, non-interventional single-arm studies. Eligible patients for the individual studies are those with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation. Only patients that have signed an informed consent form (ICF) allowing the secondary use of their data will be eligible for the CHOROS pooled analysis.
Key inclusion criteria (3 listed)
- Patients with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation
- Enrolled in on-going single-arm studies
- Provided consent for secondary use of data
Key exclusion criteria (1 listed)
- Did not provide consent for secondary use of data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide/glycopyrrolate/formoterol fumarateAlso: BGF, BreztriBudesonide/glycopyrrolate/formoterol fumarate (BGF) is a triple fixed-dose combination therapy for adults with moderate to severe COPD who are not adequately treated by a combination of inhaled corticosteroids and long-acting beta-agonist (LABA), or LABA and long-acting muscarinic-antagonist | Drug | BGF Initiators |
Primary outcome
COPD Assessment Test (CAT)
Time frame: 12 weeks
Compare self-reported COPD health status measured by COPD Assessment Test (CAT) at 12 weeks/3 months as compared to baseline in patients initiating treatment with BGF
5 secondary outcomes
COPD Assessment Test
Time frame: 4 weeks
COPD Assessment Test
Time frame: 52 weeks
COPD Assessment Test Responder Rate
Time frame: 12 weeks
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 12 weeks and 52 weeks
Annual rate of COPD exacerbations
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael F Pollack, MS principal investigator
AstraZeneca
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Germany, Greece, Italy, Japan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Assessment Test (CAT) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.